The Powerhouse for Anti-infectives –
Committed to making the difference

AiCuris is a pharmaceutical company specializing in the discovery, research, and development of novel, resistance‐breaking antiviral and antibacterial agents for the treatment of serious and potentially life-threatening infectious diseases. Founded in 2006 as a spin‐out from Bayer Infection Research, AiCuris today manages an innovative pipeline of anti-infective agents with a team of internationally recognized scientists in Research and Development. We are one of the few European biotech companies which has brought a drug with “block buster” potential to the market (Prevymis® 2017/18).

AiCuris is offering the position of a: 

CMC Expert, Biologicals (m/f/d) 

(in full time)

Reporting to the Head of Chemistry, Pharmaceutical Development and Patent Affairs

In this role you will be responsible for the co-ordination of all CMC activities (outsourcing) for all the AiCuris biological development projects.

Responsibilities

• To support development and subsequent manufacturing of biological processes from cell line development through upstream and downstream processing
• Conceptualize and lead early and late stage formulation development (liquid, lyophilized, high concentration etc.) for macromolecules (Proteins and antibodies)
• Develop and optimize processes for drug substance
• Manage activities relevant to drug product development (mixing studies, filtration studies, extractable/leachable studies etc.)
• Responsible for technology transfer from the early stage CROs  to late stage CMOs during different phases of product development
• Actively contribute to relevant part of CTD section 3 of IND/IMPD’s.
• Interpret and report results of work carried out in written and verbal format performed with  external partners
• Evaluate external developments in the area of drug substance manufacturing and formulation development

Skills and qualification

• PhD in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 3-5 years of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 8 years industrial experience
• Significant experience in protein/monoclonal antibodies/bispecifics formulation for both early and late phase development
• Experience in process development related to drug substance and drug products (lyophilization) manufacturing
• Knowledge of technology transfer and regulatory submissions in USA/EU for sections relevant to drug product development/manufacturing
• Exposure to the principles of QBD (Quality By Design) and DOE (Design of Experiment)
• Ability to manage development and manufacturing with external partners
• Experience in regulatory relationships (scientific advices)
• Fluency in English, both written and verbal
• Excellent communication skills and strong diplomacy skills required

What we can offer

• Cooperation in multinational and interdisciplinary teams
• An exciting and challenging job in a promising research and development company with an excellent R&D portfolio
• Flexible working hours and self-determined time management
• Regular and targeted further training and individual development opportunities
• Attractive company pension scheme
• A wide range of services relating to health and reconciling work and family life

How to apply

You can find a PDF of the job description here. 

Note for headhunters: We are not interested in support. Thanks!

AiCuris Anti-infective Cures AG

www.aicuris.com